PDUFA User Fee Cover Sheet 
       

FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA 

 
PDUFA User Fee Cover Sheet
Under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379g and 379h), FDA has the authority to assess and collect user fees for 
certain drug and biologics license applications and supplements. Under this 
authority, pharmaceutical companies pay fees for certain new human drug 
applications, biologics applications, and supplements submitted to the agency 
for review. Because the submission of user fees concurrently with applications 
and supplements is required, review of an application by FDA cannot begin until 
the fee has been submitted. Form FDA 3397, the PDUFA user fee cover sheet, is 
designed to provide the minimum necessary information to determine whether a fee 
is required for review of an application, to determine the amount of the fee 
required, and to help FDA track payments. 
The form provides a cross-reference of the fee submitted for an application with 
the actual application by using a unique number tracking system to assign the 
user fee payment identification number. The information collected is used by 
FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics 
Evaluation and Research (CBER) to initiate the administrative screening of new 
drug applications, biologics license applications, and supplemental 
applications. 
How to Fill Out the PDUFA User Fee Cover Sheet On-line:
FDA offers you the ability to complete a PDUFA User Fee Cover Sheet on-line and 
submit it electronically. To fill out the form online, you need Microsoft 
Internet Explorer 5.5 or higher or Netscape Navigator 4.7 or higher. To view 
instructions for checking and updating your browser, please go to: 
www.fda.gov/cber/browser.htm.
Read the instructions below and then go to the PDUFA User Fee Coversheet to fill 
out the form.
1. You will register on-line by providing the following information:
  Employer Identification Number (EIN) 
  Contact Name 
  Company Name 
  Address, City, State, Zip Code, Country 
  Daytime Telephone 
  Facsimile Number 
  E-mail 
  Dun & Bradstreet Number (DUNS) 
2. Fill out the PDUFA User Fee Cover Sheet. Please answer a series of questions 
regarding the type of application being submitted for FDA's review. You will 
have the opportunity to view the cover sheet in draft form before submitting it 
to FDA. You have not submitted your cover sheet until you receive a user fee 
payment identification number. 
3. When you are done, click the SUBMIT button to complete the cover sheet 
submission process. A form will appear with an electronically generated user fee 
payment identification number that is located in the upper right-hand corner, 
beginning with the letters PD. This number will assist FDA in tracking your 
payment and submission for the review process. Please print a copy for your 
files to send with your payment and for your submission to CDER and CBER. 
Submitting Payment
Please send a printed copy of the completed PDUFA User Fee Cover Sheet along 
with a check, bank draft, or U.S. Postal money order made payable to the Food 
and Drug Administration for the fee amount due. Remember to include the user fee 
payment identification number, beginning with "PD", the BLA/NDA number, and the 
FDA P.O. Box on the enclosed check. 
Mail payment and copy of PDUFA user fee cover sheet to:
Food and Drug Administration
P.O. Box 360909
Mellon Client Service Center -- Room 670
500 Ross Street
Pittsburgh, PA 15251-6909
Note: In no case should payment be submitted with the application.
If checks are to be sent by a courier that requires a street address, the 
courier can deliver the checks to:
Food and Drug Administration (360909)
Mellon Client Service Center - Room 670
500 Ross Street
Pittsburgh, PA 15262-0001
Note: This address is for courier delivery only. 
If You Have Problems:
If you are unsure whether or not you need to file an application with FDA or are 
unsure what type of application to file:
Contact: Bev Friedman or Mike Jones at 301-594-2041
FDA Center for Drug Evaluation and Research
Contact: Carla Vincent at 301-827-3503
FDA Center for Biologics Evaluation and Research
If you need technical assistance with your cover sheet or are unsure how to 
proceed.
Contact: FDA User Fee Financial Support Team at (301) 827-9539 or 
userfees@fda.gov. 
PDUFA User Fee Cover Sheet
OMB No. 0910-0297
Form FDA 3397 (12/06)

PDUFA Home Page
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | 
Accessibility
FDA Website Management Staff